Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue

The University of Alabama at Birmingham

Status and phase: Withdrawn; Phase 2

Conditions: Root Canal Therapy

Treatments: Drug: Collagen Scaffold (Colla-Plug); Drug: Collagen-hydroxyapatite scaffold (Syn-Oss)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03613090

IRB-161031003

Details and patient eligibility

About

The purpose of this investigation is to assess the use of a novel scaffold (an FDA-approved collagen-hydroxyapatite material called Syn-Oss) for regeneration of pulp tissues versus the use of a traditional scaffold (blood clot).

Full description

Regeneration of pulp tissues in teeth with immature roots is a new concept based on historical limited success using calcium hydroxide dressings placed into debrided pulp spaces. Obtaining stem cells from the apical papilla (SCAP cells), which are present at the base of all teeth, but are most accessible in teeth with immature apices, greatly enhances clinical success. Current therapies lack ideal messenger chemicals and scaffolds to optimize results.

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Single root canal space apparent on a standard dental periapical radiograph
2. Immature tooth apex width at least 1.1mm in diameter as measured from the radiograph
3. No history of antibiotic drug allergy
4. Necrotic pulp as demonstrated by coronal discoloration.
5. Periapical radiolucency
6. Negative pulp sensibility tests
7. Other standard clinical means of assessing pulp vitality status

Exclusion criteria

1. Any patients having an American Association of Anesthesiologists 4 health classification will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Collagen-hydroxyapatite Scaffold (Syn-Oss)

Experimental group

Description:

Placement of a collagen-hydroxyapatite scaffold (Syn-Oss), placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material).

Treatment:

Drug: Collagen-hydroxyapatite scaffold (Syn-Oss)

Collagen Scaffold (Colla-Plug)

Active Comparator group

Description:

Placement of a collagen scaffold (Colla-Plug) over a blood clot, placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material). The Colla-Plug material is placed adjacent to the blood clot that has formed inside the root canal space. It act as a matrix for the subsequent placement of the mineral trioxide aggregate material. It has been used as the standard of care in regenerative endodontics since 2004.

Treatment:

Drug: Collagen Scaffold (Colla-Plug)